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Added 6 mins ago
Commercial Specialist – ALTO project / Cadence
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Full-time
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Commercial Specialist – ALTO project / Cadence
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Emergent Biosolutions

Sr Director, Engineering & Fac. & Validation

Winnipeg, MB, R3T 5Y3, Canada

Experience: Minimum of 15 years of experience in a senior engineering capacity with a strong preference for experience in a biopharmaceutical environment
Posting language: English
Posted: Aug 8, 2026

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Original job description

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

JOB SUMMARY

Lead the Engineering, Facilities, and Validation (EFV) team at a site. Serve as a member of the Site Leadership Team and provide direct management of EFV staff. Ensure that both site and global objectives are achieved through the support of the EFV team. Deliver on site EFV objectives while implementing harmonized EFV systems and processes. Provide leadership support to the other sites and global initiatives as needed.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Provide leadership and direction to EFV team members, driving performance to the site and function operational and strategic plans, while establishing governance, performance expectations, and accountability aligned with organizational EFV strategy and standards
Ensure effective systems, processes, and governance are in place to deliver maintenance, facilities, validation, engineering, EHS and protective services activities in a compliant, reliable and efficient manner
Oversight of the full validation lifecycle (commissioning, qualification, and continued
Own and ensure execution of the site Validation Master Plan (VMP), including alignment with global standards and integration with capital projects, operations, and quality systems
Provide leadership oversight of validation-related quality systems, including change control, deviations, CAPA, and periodic review processes, ensuring compliance and continuous improvement
Establish and drive risk-based validation strategies to ensure compliant, efficient, and scalable validation approaches aligned with regulatory expectations and industry best practices, processes and consistent with cGMP requirements
Ensure adequate resourcing (capacity and capability) to accomplish site and EFV objectives including proactive workforce planning and alignment to capital and operational priorities
Drive on-going development of the EFV team and the personal development of EFV team members, and build organizational capability to support current operations and future site and network growth
As a Site Lead Team Member, interface with senior internal stakeholders, external partners and regulatory agencies to represent EFV capabilities and ensure alignment and delivery on strategy and operational priorities
Own governance and delivery of the site master plan, 5-year and annual capital portfolio, including prioritization, resource allocation, and performance against cost, schedule, and scope targets, consistent with site master plans and long-range planning objectives
Lead and influence cross-site EFV harmonization initiatives, ensuring adoption of best practices and consistent execution at the site and network level
Escalate issues though site and/or function management as appropriate, and serve as the senior EFV escalation point for complex technical, operational, and capital-related issues
Continuously improve the culture of the EFV team and the site including driving engagement, accountability, and a high-performance culture aligned with company values
Actively shape and influence EFV functional strategy, providing input and leadership on priorities, investments, and performance improvement initiatives
Lead and/or support strategic opportunity evaluations, including site expansions, new capabilities, and major capital investments
Serve as the senior EFV representative during regulatory inspections and audits, ensuring inspection readiness and compliance across engineering, facilities, and validation systems

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

EDUCATION, EXPERIENCE, SKILLS

Minimum of 15 years of experience in a senior engineering capacity with a strong preference for experience in a biopharmaceutical environment
Demonstrated experience leading and/or governing significant capital programs in a regulated manufacturing environment (e.g., large-scale facility expansions, infrastructure upgrades, or complex capital portfolios)
Deep understanding of validation lifecycle principles, including commissioning, qualification, continued process verification, and validation program governance in cGMP environments
Technology/Equipment (Drug Product/Drug Substance/Clinical/Commercial/Stainless Steel/Single Use) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and reliability for these technologies.
Ability to lead at both strategic and operational levels, translating enterprise objectives into executable site and functional plans
Highly effective verbal and written communicator at all levels of the organization
Demonstrated ability to effectively prioritize and coordinate activities
Proficiency in Microsoft Office applications
BS in Engineering, Science, or Management or equivalent experience
Licensed Professional Engineer (PE, CFM, PMP) or advanced technical or business degrees a plus

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

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More about this job

Responsibilities

Lead the Engineering, Facilities, and Validation (EFV) team at the site while serving as a member of the Site Leadership Team. Ensure operational excellence, regulatory compliance, and the successful execution of capital projects and validation master plans.

Requirements

Requires a minimum of 15 years of experience in a senior engineering capacity, preferably within a biopharmaceutical environment. Candidates must possess a strong understanding of cGMP requirements, validation lifecycle principles, and experience managing large-scale capital programs.

Skills

Engineering management
Facilities management
Validation lifecycle
cGMP compliance
Capital project management
Strategic planning
Risk-based validation
Regulatory inspection readiness
Cross-functional leadership
Operational excellence
Workforce planning
Quality systems
Change control
Deviation management
CAPA
Stakeholder management

Benefits

Competitive salaries
Flexible work arrangements
Extensive benefits package

Visa sponsorship

Not detected in the job text

Keywords

Engineering
Facilities
Validation
Biopharmaceutical
cGMP
Capital projects
Validation Master Plan
Quality systems
Change control
CAPA
Risk-based validation
Regulatory inspections
Infrastructure upgrades
Operational safety
Site leadership
Strategic planning
Commissioning
Qualification
Process verification
Professional Engineer
PMP
CFM
Manufacturing
Compliance
Governance
Performance management
Workforce planning
Stakeholder management
Drug product
Drug substance

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